AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry

Recruiting now

Conditions studied: Bradycardia, Atrio-Ventricular Block, Syncope

In brief

This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.

Key facts

Study ID

NCT06854484

Run by

Royal Brompton & Harefield NHS Foundation Trust

People needed

300

Starts

2025-04-15

Expected to finish

2032-09-01

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
• Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).

You may not qualify if…

• Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
• Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
• Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC

Where it is running

• Royal Brompton Hospital — London, UK, United Kingdom (enrolling)
• The Royal Brompton Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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